No More Paper Chase: Product Life Cycle Systems That Make Sense

GUIDE TO OUTSOURCING: EDITOR'S PAGE

As medical device companies increase product output, the onus is on them to manage quality and performance. But according to a recent survey, medical device OEMs have a long way to go with adoption of total product life cycle (TPLC) management.

The survey, based on 212 responses from various medical device companies, found that 80% of the organizations rely on some form of paper for official recordkeeping. And more than 60% use paper or homegrown systems (e.g., spreadsheets or databases) to document audit findings, corrective and preventive actions, field issues, and complaints.
Such systems can dramatically limit how a company approaches an outsourced project, which was identified as a key challenge by respondees. “There is a lot of pressure for medical device companies to manage complex production landscapes [so that they are] effective and efficient,” says Julie Fraser, president of Cambashi (Cummaquid, MA), a management consulting firm that conducted the study.
“As soon as you outsource something, you no longer have the same degree of control,” Fraser says. “It's an opportunity for misunderstanding that can affect the end-to-end process.” Not having a proper life cycle system can exacerbate an already challenging situation, she says.
“The study showed us that many companies are working with paper-based systems, and that's where information can be disconnected,” Fraser says. “One piece of paper may have been superseded by a new piece of paper.”
OEMs must have mechanisms in place to ensure accountability on all sides, says Fraser. The TPLC study made recommendations on how to do so, described as follows:
•Implement processes that support closed-loop feedback systems.•Use tools to assess true root causes. •Create structured agreements and full visibility across the entire value chain.
Fraser says the third bullet point is most significant for managing outsourcers. Manufacturers and their outsourcers are challenged to create visibility within product development processes in a way that makes it difficult for errors to occur. She says a critical way to do that is to create a system that emphasizes concurrent, rather than sequential development processes. Doing so, she says, enables outsourcers, suppliers, and OEMs to all view the same set of information at the same time. “They all need to be sharing to build on each other's knowledge base.”
If a device manufacturer creates milestones, it needs to follow up to make sure those milestones are met, Fraser says. TPLC management gives the OEM and the outsourcers the same data so that each knows how they are being measured. “Having that visibility in both directions can make the relationship stronger,” says Fraser.
Heather Thompson
for the Editors